Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Patients With Richter's Transformation and Leukemias

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00472849
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oxaliplatin — DRUG
    Oxaliplatin 30 mg/m\^2/day, over approximately 2 hours, before fludarabine is started, on days 1-4.
  • Fludarabine — DRUG
    Fludarabine 30 mg/m\^2 daily IV, over approximately 30 minutes, on days 2-3, 2-4, or 2-5 until maximum tolerated dose is reached.
  • Cytarabine — DRUG
    Cytarabine 500 mg/m\^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose is started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose is reached.
  • Rituximab — DRUG
    Rituximab 375 mg/m\^2 IV on day 3, course 1 (on day 1, subsequent courses).
  • Pegfilgrastim — DRUG
    6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy

Study Details

The goal of this clinical research study is to find the highest tolerable dose of fludarabine and cytarabine that can be given in combination with oxaliplatin and rituximab in the treatment of chronic lymphocytic leukemia (CLL), prolymphocytic leukemia, or Richter's transformation. Once the highest tolerable dose for this drug combination is found, the next goal of the study will be to find out if this combination therapy is effective in shrinking or slowing the growth of these diseases.

Key Dates

Start date
May 31, 2007
Status verified
Nov 2013
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012

Study Design

Enrollment
92 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: OFAR (Phase I)
    Oxaliplatin starting dose 30 mg/m\^2/day over 2 hours on days 1-4 before Fludarabine. Fludarabine 30 mg/m\^2 daily intravenous (IV) over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m\^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose (MTD) reached. Rituximab 375 mg/m\^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
  • Experimental: OFAR MTD (Phase II)
    Oxaliplatin 25 mg/m\^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m\^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m\^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m\^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.

Primary Outcome Measure

Maximum Total Tolerated Dose (MTD) of Daily Combination Fludarabine 30 mg/m^2 and Cytarabine 500 mg/m^2 Among 3 Dose Levels (Dose Level 1: 2 Days, Dose Level 2: 3 Days or Dose Level 3: 4 Days) [ Time Frame: Up to 36 weeks (6 cycles each 4-6 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
UT MD Anderson Cancer Center· Houston, TX

Related Studies